DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered but are not persuasive.
Applicant first argues that the cited prior art fails to disclose or teach “the calculation and detection unit is configured to compute a grinding area or a grinding volume on the artificial bone block after a grinding operation is performed on the artificial bone block by the surgical instrument according to the spatial position of the surgical instrument”, as required by amended claim 6 (Remarks, filed 06/29/26, pp. 4-6). Examiner respectfully disagrees. Han (CN111134846A) explicitly discloses “the spatial coordinate information of the detection probe obtained in step S230 can be regarded as the actual positioning of the system after surgical planning and operation.” (emphasis added) (Han, p. 10, ln. 28-p. 11, ln. 15; p. 12, ln. 17-31, where the detection probe is a grinding head; see further Han, p. 14, ln. 19-29, “Since the detection probe 130 is used to simulate the grinding head in the system, the coordinate system can be regarded as the actual coordinate system of the grinding head in operation.”). Accordingly, Han discloses computing the grinding area on the artificial bone block after a grinding operation is performed on the artificial bone block by the surgical instrument according to the spatial position of the surgical instrument (the actual positioning of the system after surgical operation). It is noted that the spatial coordinate information of the detection probe is further compared to a theoretical position of the active grinding surgical robot system to determine positioning accuracy of the system (Han, p. 12, ln. 24-p. 13, ln. 6). Moreover, it is noted that the plug gauges in Han are used to determine a grinding volume, which is distinct from a grinding area.
Applicant further argues that Barsoum fails to teach “a bone part of the patient has an external structure part, and the artificial bone block includes an outer part and hardness of the outer part corresponds to the bone density of the external structure part”, as required by amended claim 6 (Remarks, filed 06/29/26, p. 6). Examiner respectfully disagrees. Barsoum (U.S. Pub. 2014/0272881 A1) teaches a three-dimensional model of native tissue having patient-specific physical characteristics including bone density used for preparing for and simulating the effects of surgery, where a first (outer) area of the model has a first area density corresponding to a hard tissue portion of the native tissue that is greater than a second (inner) area density (Fig. 2; [0014-0015]). Accordingly, Barsoum teaches where the artificial bone block (three-dimensional model) includes an outer part and hardness of the outer part that corresponds to the bone density of an external structure part of a bone part of the patient.
For these reasons, the claims remain rejected under 35 U.S.C. 103.
Claim Objections
Claims 6 and 9 are objected to because of the following informalities:
“block structure, the calculation and detection unit is configured to compute a” recited in claim 6, ln. 15 should likely read “block structure, and the calculation and detection unit is configured to compute a”; and
“a bone part” recited in claim 9, ln. 2 should likely read “[[a]]the bone part”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites in part “the calculation and detection unit is configured to detect a spatial position of the surgical instrument according to the spatial positioning of the verification block structure, the calculation and detection unit is configured to compute a grinding area or a grinding volume on the artificial bone block after a grinding operation is performed on the artificial bone block by the surgical instrument according to the spatial position of the surgical instrument”. However, it is indefinite as to what is meant by “spatial position” of the surgical instrument (i.e., a single point versus a trajectory, inclusion of orientation, etc.), and thus further how the spatial position of the surgical instrument relates to the grinding area or grinding volume computation, and the Specification does not offer further guidance.
Claims 7-9 are rejected by virtue of their dependencies on claim 6.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Han et al. (CN111134846A) (hereinafter “Han”) in view of Kheradpir et al. (U.S. Pub. 2020/0281659 A1) (hereinafter “Kheradpir”) and Barsoum (U.S. Pub. 2014/0272881 A1).
Regarding claim 6, Han discloses a verification system for an orthopedic surgery (Fig. 1; p. 8, ln. 32-p. 9, ln. 8), comprising:
a surgical instrument (Fig. 3, probe 130; Fig. 5, S230; p. 10, ln. 28-p. 11, ln. 15; p. 12, ln. 17-23; p. 16, ln. 5-9);
a verification block structure (Fig. 1; p. 8, ln. 32-p. 9, ln. 8), including:
a base having a carrying portion and a bottom corresponding to the carrying portion (Fig. 1; p. 3, ln. 8-9; p. 9, ln. 8-24, base (frame) 110 having carrying portion (mounting portion 111 and mounting block “P”) and a bottom “T”);
an artificial bone block detachably fixed to the carrying portion of the base (Fig. 1, test mold 120; p. 3, ln. 10-11; p. 9, ln. 8-27, the test mold used to simulate the human bone to be ground in the active grinding operation and which is detachably installed on the frame); and
a calculation and detection unit comprising a processor and a memory (p. 16, ln. 26-31, wherein the described method for detecting the accuracy of the active grinding surgical robot system can be implemented by the host computer of the system, wherein a computer comprises a processor and a memory),
wherein the calculation and detection unit is configured to obtain a spatial positioning of the verification block structure (Fig. 2; p. 3, ln. 14-18; p. 10, ln. 12-27; p. 13, ln. 15-17, wherein the spatial coordinate information of the frame 110 can be measured via a plurality of marking points 112A-112D, or spherical sockets arranged adjacent to the long sides of the rectangle frame, which are distinguishable by a medical imaging device and also by a spatial positioning device), the calculation and detection unit is configured to detect a spatial position of the surgical instrument according to the spatial positioning of the of the verification block structure, the calculation and detection unit is configured compute a grinding area or a grinding volume on the artificial bone block after a grinding operation is performed on the artificial bone block by the surgical instrument according to the spatial position of the surgical instrument (p. 4, ln. 19-p. 5, ln. 2; p. 10, ln. 28-p. 11, ln. 15; p.11, ln. 31-p. 12, ln. 6; p. 12, ln. 17-31, where spatial coordinate information of the probe (actual positioning of the system after surgical operation, or grinding area after grinding operation is performed) is obtained, wherein this information may then be used to calculate a transformation relationship between the spatial positioning of the frame/test mold (theoretical positioning of the active grinding surgical robot system) and the spatial positioning of the probe (actual positioning of the system after surgical operation) to indicate a deviation between the actual positioning after operation (grinding area after grinding operation is performed) and the theoretical positioning).
Han may not explicitly disclose the verification block structure further including a plurality of infrared reflective balls disposed on a side surface of the base configured for position tracking, wherein the calculation and detection unit is configured to obtain a spatial positioning of the verification block structure according to the plurality of infrared reflective balls. Rather, Han discloses a plurality of marking points (spherical sockets) located at positions of the frame for determining the spatial coordinate information of the frame using a spatial position measuring device (measuring device) (Fig. 2; p. 3, ln. 14-18; p. 10, ln. 12-27; p. 13, ln. 15-17). However, Kheradpir, directed to a calibration apparatus for a medical tool ([0002]), teaches a calibration apparatus comprising a frame which includes frame tracking markers disposed in relation to a same side of the frame, wherein the frame tracking markers may be spherical infrared markers and wherein the location (spatial positioning) thereof is detected by a camera and calculated by a control and processing unit (Figs. 6-13; [0100]; [0103]; [0108]; [0114], frame tracking markers 604 attached to frame 602 of calibration apparatus 600).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the spherical socket marking points in Han for infrared reflective balls/spheres for position tracking, as taught by Kheradpir, in order to obtain the spatial positioning of the verification block structure (Kheradpir, [0100]; [0103]; [0108]; [0114]; see further Specification, [0019-0020], “the marking elements 141 to 144 can be infrared reflective balls, but the present disclosure is not limited thereto. Since position tracking of the marking elements 141 to 144 are known to those skilled in the art, the details thereof shall not be repeated herein.”).
Han may not further explicitly disclose wherein the artificial bone block has a distribution of bone density similar to a measured distribution of bone density of the patient, and further, wherein a bone part of the patient has an external structure part, and the artificial bone block includes an outer part and hardness of the outer part corresponds to a bone density of the external structure part. Rather, Han discloses wherein the test mold (artificial bone block) used to simulate human bones is of a predetermined size and shape and made of materials similar to that of human bone with respect to, for example, hardness and heat resistance, wherein the bone part of the patient inherently has an external structure part and wherein the artificial bone block (test mold) includes an outer part (Fig. 1; p. 3, ln. 10-11; p. 4, ln. 7-8; p. 9, ln. 25-35; p. 15, ln. 7-12). However, Barsoum, directed to a patient-specific three dimensional model of native tissue used for preparing for surgery ([0002]), teaches wherein a patient-specific physical characteristic of the three-dimensional model includes bone density, and wherein a first (outer) area has a first area density corresponding to a hard tissue portion of the native tissue that is greater than a second (inner) area density corresponding to a soft tissue portion of the native tissue (Fig. 2; [0014-0015]; [0019-0022], wherein, to recreate the three-dimensional model, images of the patient’s native tissue are first taken). It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to model a distribution of bone density similar to that measured of a patient in the simulation of human bones, as taught by Barsoum, in the invention of Han to allow a user to more accurately determine the effects of surgery on the native tissues of the patient (Barsoum, [0014]).
Regarding claim 7, Han further discloses wherein the artificial bone block and the carrying portion are provided (p. 9, ln. 19-24, wherein the test mold 120 is installed on the mounting portion 111 by mounting block P), a mortise is further formed on the carrying portion (Figs. 1A-2, mortise located in mounting portion 111 through which test mold 120 is inserted), the artificial bone block has a tenon portion corresponding to the mortise (Figs. 1-2), and the artificial bone block is detachably fixed on the carrying portion (Figs. 1-2; p. 9, ln. 19-26; p. 10, ln. 1-4, wherein the test mold is detachably installed on the mounting portion 111 of the frame 110 by mounting block P).
Han may not further explicitly disclose wherein the artificial bone block and the carrying portion are provided with a plurality of fastening points at corresponding positions, and wherein the artificial bone block is detachably fixed on the carrying portion by at least one fastener. However, Han discloses wherein the test mold can be detachably installed on the frame by other fixing methods, aside from using mounting block P (p. 7, ln. 27-p. 8, ln. 2; p. 10, ln. 1-4, wherein “installed” should “be understood in a broad sense, for example, it can be fixed connection or detachable connected or integrally connected; may be mechanical, electrical, or may communication with each other”). Accordingly, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to detachably fix the artificial bone block (test mold) on the carrying portion of Han by at least one fastener (e.g., screws, such as those used to attach the bottom “T” (p. 9, ln. 13-14)) and utilizing corresponding fastening points as a matter of design choice as an alternative and/or additional method for detachably installing the artificial bone block on the frame. It is noted that the Specification fails to disclose a particular advantage or solved problem for providing a plurality of fastening points at corresponding positions of the artificial bone block and carrying portion, or for detachably fixing the artificial bone block on the carrying portion by at least one fastener (see Specification, [0020-0021], “It should be noted that, in order to detachably fix the artificial bone blocks 131 to 133 on the carrying portion 111, the artificial bone blocks 131 to 133 and the carrying portion 111 can be provided with a plurality of fastening points at corresponding positions (for example, screw locking points 151, 152, 153 and 154 of FIGS. 1A to 1C), such that the user can detachably fix the artificial bone blocks 131, 132, 132, and 133 to the carrying portion 111 by using at least one fastener (e.g., screws 161 and 162 in FIGS. 1A to 1C). In addition, as shown in FIG. 1A to FIG. 1C, a mortise 171 can be further formed on the carrying portion 111, and the artificial bone blocks 131, 132 and 133 each have a tenon portion corresponding to the mortise 171, such that the user can also use the mortise 171 and the tenon portion to detachably fix the artificial bone blocks 131, 132, and 133 on the carrying portion 111, but the present disclosure does not limit specific implementations for detachably fixing the artificial bone blocks 131, 132, and 133 on the carrying portion 111.”). A person of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the mounting portion 111 and mounting block “P” of Han because said components serve the same functions/achieve the same result to detachably fix the artificial bone block (test mold) for the purpose of performing a grinding operation on simulated human bone (Han, p. 9, ln. 19-26; p. 10, ln. 1-4). Therefore, it would have been an obvious matter of design choice to modify Han to obtain the invention as specified in the claim.
Regarding claim 8, Han further discloses wherein a shape of the artificial bone block is determined upon a surgical method (p. 9, ln. 25-35; p. 15, ln. 7-9, wherein the specific shape and size of the test mold prior to grinding (surgical method) may be configured according to the circumstances of practice (actual needs/situation (i.e., grinding operation))), and the surgical method is drilling, cutting, scraping or grinding (p. 9, ln. 25-35; p. 11, ln. 31-p. 12, ln. 6, wherein the surgical method is grinding).
Regarding claim 9, Han further discloses wherein the artificial bone block imitates a bone part of the patient (p. 3, ln. 10-11; p. 4, ln. 7-8; p. 9, ln. 25-27, wherein the test mold (artificial bone block) is used to simulate a human bone to be ground), and is used to simulate and verify the drilling, cutting, scraping or grinding of the bone part (p. 4, ln. 7-8; p. 9, ln. 25-35; p. 11, ln. 31-p. 12, ln. 6, the test mold used to simulate the human bone operated in the active grinding operation).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA N BIANCAMANO whose telephone number is (571)272-4280. The examiner can normally be reached M-F: 8:30am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dmitry Suhol, can be reached at (571)272-4430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA N BIANCAMANO/Examiner, Art Unit 3715
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